{"id":8088,"date":"2016-05-22T15:25:45","date_gmt":"2016-05-22T19:25:45","guid":{"rendered":"http:\/\/blogs.nejm.org\/hiv-id-observations\/?p=8088"},"modified":"2016-05-22T15:25:45","modified_gmt":"2016-05-22T19:25:45","slug":"drug-prior-authorizations-blunt-tool-cost-containment-theyre-annoying","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/drug-prior-authorizations-blunt-tool-cost-containment-theyre-annoying\/2016\/05\/22\/","title":{"rendered":"Drug Prior Authorizations Are a Very Blunt Tool for Cost Containment &#8212; And They&#8217;re Annoying"},"content":{"rendered":"<p><a href=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/2001-ape.jpg\" rel=\"attachment wp-att-8090\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-8090\" src=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/2001-ape-300x177.jpg\" alt=\"2001-ape\" width=\"300\" height=\"177\" srcset=\"https:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/2001-ape-300x177.jpg 300w, https:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/2001-ape.jpg 500w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a>Insurance prior authorizations, or prior approvals (PAs) &#8212; those dreaded forms clinicians have to fill out, usually triggered by prescribing a\u00a0non-formulary drug &#8212; are much on my mind these days. And most of it has to do with three letters, specifically &#8220;TAF.&#8221;<\/p>\n<p>As readers of this site probably\u00a0know, there are now three tenofovir alafenamide (TAF)-based coformulations approved for HIV treatment, all theoretically\u00a0available for prescription alongside the older tenofovir disoproxil fumarate (TDF)-forms. In comparative clinical trials, TAF has\u00a0consistently had a more favorable effect on bone and renal health than TDF &#8212; a benefit of considerable importance to older patients with HIV.<\/p>\n<p>Why do I bring up these older patients? If you&#8217;ve been doing HIV clinical care for a while, your patient population is probably a lot like mine:<\/p>\n<ul>\n<li><strong>Of a certain vintage<\/strong> &#8212; note I didn&#8217;t say &#8220;old&#8221;, though <a href=\"http:\/\/www.brainyquote.com\/quotes\/quotes\/b\/bernardbar119897.html\" target=\"_blank\">this apt\u00a0definition<\/a> isn&#8217;t far off the mark. In one of my patient sessions last week, the average age was\u00a057 (range 45 &#8211; 71); for the record, the oldest patient with HIV seen in our practice last week\u00a0was 88.<\/li>\n<li><strong>On HIV treatment for a long time<\/strong>\u00a0&#8212;\u00a0often\u00a0more than a decade.<\/li>\n<li><strong>Virologically suppressed<\/strong> &#8212; they are great at taking their antivirals.<\/li>\n<\/ul>\n<p>These characteristics mean that AIDS-related complications are\u00a0<em>very<\/em> unlikely\u00a0to happen. If I found out that one of my stable HIV patients\u00a0were hospitalized after being struck by a meteorite\u00a0or falling satellite, this would surprise me only a little more than if one were admitted with\u00a0<em>Pneumocystis<\/em> pneumonia. If we consider\u00a0the health concerns of these individuals, non-AIDS diseases are far more likely to occur than those\u00a0related to HIV.<\/p>\n<p>And while we clinicians\u00a0can&#8217;t control the random showering of space debris, we can try to minimize drug toxicity &#8212; which brings me back to the TAF-based HIV treatments, and whether we should be using them, and in whom.<\/p>\n<p>I&#8217;d argue\u00a0that these older HIV patients are ideal candidates for TAF (as opposed to TDF) -based drugs, and I&#8217;ve found myself wanting to switch them from TDF to TAF multiple\u00a0times each week.\u00a0Aging intrinsically leads to declines in renal function and bone density, and increases the likelihood that there will be comorbid conditions further impacting the kidneys and bones (hypertension, diabetes, menopause for women). Furthermore, a patient&#8217;s\u00a0lengthy HIV treatment often\u00a0means that they\u00a0have been on TDF for a <em>long time<\/em> &#8212; probably the most important\u00a0risk factor for clinically important TDF-induced toxicity.<\/p>\n<p>This clinical reasoning, however, is currently lost on most of the payers, who have set up their favorite tool &#8212; the &#8220;PA&#8221; (cue scary music here) &#8212; to discourage use of these new drugs.<\/p>\n<p>As far as I can tell, it&#8217;s not that they have critically reviewed the data comparing TAF with TDF, and concluded that they disagree, or find it scientifically inaccurate. It&#8217;s simply that the TAF treatments are new, and new means you have to jump through hoops to get it.<\/p>\n<p>Or, even worse, you can&#8217;t get it at all. Here&#8217;s an email I received from a pharmacist trying to help me on one of these cases, this for\u00a0a 70-year-old man\u00a0with osteopenia currently on TDF\/FTC in whom I thought TAF\/FTC would be a safer\u00a0choice:<\/p>\n<blockquote><p><span style=\"line-height: 1.5\">The medication is not covered and is excluded from coverage because it is a new drug to market. [Insert payer or pharmacy management company here]\u00a0said that a review for coverage is not possible and that an appeal would be denied outright. \u00a0They also said that a letter of medical necessity would not help to obtain coverage, either.<br \/>\n<\/span>Thank you! Have a nice day!<br \/>\nDan<\/p><\/blockquote>\n<p>Glad he can be so cheerful!<\/p>\n<p>Look, I get it &#8212; drug costs are high, and PAs\u00a0theoretically are a way of avoiding inappropriate use of new, more costly agents when older drugs would do the job just as well.<\/p>\n<p>And though all\u00a0three of the TAF formulations are cost-neutral to the older TDF treatments based on Average Wholesale Price, one has to assume there have been negotiations on price between the payers and manufacturers with TDF, deals that haven&#8217;t yet been made with TAF. (Or made public to us or\u00a0our patients &#8212; &#8220;transparent&#8221; is never the word used to describe these deals.)<\/p>\n<p>In addition, payers may well be looking forward to generic TDF, which is scheduled to become available next year and presumably would cost even less. It presumably will be easier to switch patients to generic TDF from branded TDF than from TAF, as a TAF to TDF switch could be viewed as switching to a potentially more toxic drug. Who would do that?<\/p>\n<p>But are these mandatory\u00a0PAs really the right way to decide whether a treatment is indicated &#8212; based solely on whether it&#8217;s new, and whether the clinician and his\/her team have the endurance to fill them all out?\u00a0Colleagues of mine delve deeper into the TAF vs TDF cost issues <a href=\"http:\/\/cid.oxfordjournals.org\/content\/62\/7\/915.full#aff-5\" target=\"_blank\">here<\/a>, a welcome review of the relative values of these two drugs.<\/p>\n<p>Meanwhile, over on an insurance company&#8217;s <a href=\"http:\/\/www.bcbsm.com\/index\/health-insurance-help\/faqs\/plan-types\/pharmacy\/why-do-i-need-prior-authorization-for-prescription-drug.html\" target=\"_blank\">web page<\/a>, they list the reasons behind PAs\u00a0as follows:<\/p>\n<p><a href=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/Screen-Shot-2016-05-22-at-2.10.05-PM.png\" rel=\"attachment wp-att-8089\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-8089\" src=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/Screen-Shot-2016-05-22-at-2.10.05-PM.png\" alt=\"Screen Shot 2016-05-22 at 2.10.05 PM\" width=\"488\" height=\"166\" srcset=\"https:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/Screen-Shot-2016-05-22-at-2.10.05-PM.png 488w, https:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/05\/Screen-Shot-2016-05-22-at-2.10.05-PM-300x102.png 300w\" sizes=\"auto, (max-width: 488px) 100vw, 488px\" \/><\/a><\/p>\n<p>As far as I can tell, bullet #5 is by far the most common reason for a PA &#8212;\u00a0especially if the drug is new.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Insurance prior authorizations, or prior approvals (PAs) &#8212; those dreaded forms clinicians have to fill out, usually triggered by prescribing a\u00a0non-formulary drug &#8212; are much on my mind these days. And most of it has to do with three letters, specifically &#8220;TAF.&#8221; As readers of this site probably\u00a0know, there are now three tenofovir alafenamide (TAF)-based [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,8,9],"tags":[423,1095,901],"class_list":["post-8088","post","type-post","status-publish","format-standard","hentry","category-health-care","category-hiv","category-patient-care","category-policy","tag-hiv","tag-taf","tag-tdf"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/8088","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/comments?post=8088"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/8088\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=8088"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=8088"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=8088"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}